Safety, Tolerability, and Pharmacokinetics of Escalating Single Doses of TAK-935

NCT02201056 | Completed Phase 1 Results

• 2 other identifiers: TAK-935_101U111-1155-6022
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to characterize the safety and tolerability profile of TAK-935 in healthy participants when administered as a single dose of oral solution at escalating dose levels.

Conditions

Healthy Volunteers

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (4)

• Percentage of Participants Who Experience at Least One Treatment-emergent Adverse Event (TEAE)

  An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug and within 30 days after the last dose of study drug.

  Day 1 to Day 30

• Percentage of Participants Who Meet the Markedly Abnormal Criteria, for Safety Laboratory Tests at Least Once Post-dose

  The percentage of participants with any markedly abnormal standard safety laboratory values (hematology, serum chemistries, and urinalysis) collected during the treatment period.

  Day 1 to Day 14

• Percentage of Participants Who Meet Markedly Abnormal Criteria, for Vital Sign Measurements at Least Once Post-dose

  The percentage of participants with any markedly abnormal vital signs (oral temperature, respiration rate, pulse, and blood pressure) collected during the treatment period.

  Day 1 to Day 14

• Percentage of Participants Who Meet the Markedly Abnormal Criteria, for Electrocardiogram (ECG) Measurements at Least Once Post-dose

  The percentage of participants with any markedly abnormal criteria for standard 12-lead ECG measured collected during the treatment period.

  Day 1 to Day 14

Secondary Outcomes (3)

• Cmax: Maximum Observed Plasma Concentration for TAK-935

  Multiple time-points (Up to 96 hours) post-dose

• AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-935

  Multiple time-points (Up to 96 hours) post-dose

• AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity of TAK-935

  Multiple time-points (Up to 96 hours) post-dose

Study Arms (7)

Cohort 1: TAK-935 15 mg

EXPERIMENTAL

TAK-935 15 mg solution, orally, once, on Day 1.

Drug: TAK-935

Cohort 2: TAK-935 50 mg

EXPERIMENTAL

TAK-935 50 mg solution, orally, once, on Day 1.

Drug: TAK-935

Cohort 3: TAK-935 200 mg

EXPERIMENTAL

TAK-935 200 mg solution, orally, once, on Day 1.

Drug: TAK-935

Cohort 4: TAK-935 600 mg

EXPERIMENTAL

TAK-935 600 mg solution, orally, once, on Day 1.

Drug: TAK-935

Cohort 5: TAK-935 900 mg

EXPERIMENTAL

TAK-935 900 mg solution, orally, once, on Day 1.

Drug: TAK-935

Cohort 6: TAK-935 1350 mg

EXPERIMENTAL

TAK-935 1350 mg solution, orally, once, on Day 1.

Drug: TAK-935

Cohorts 1-6: Placebo

PLACEBO COMPARATOR

TAK-935 placebo-matching solution, orally, once, on Day 1.

Drug: Placebo

Interventions

TAK-935 DRUG

TAK-935 oral solution

Cohort 1: TAK-935 15 mg; Cohort 2: TAK-935 50 mg; Cohort 3: TAK-935 200 mg; Cohort 4: TAK-935 600 mg; Cohort 5: TAK-935 900 mg; Cohort 6: TAK-935 1350 mg

Placebo DRUG

TAK-935 placebo-matching oral solution

Cohorts 1-6: Placebo

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Is a healthy male or female adult who is 19 to 55 years of age inclusive at the time of informed consent.
• Weighs at least 45 kg and has a body mass index (BMI) between 18.0 and 30.0 kg/m\^2, inclusive at the Screening Visit.

You may not qualify if:

• Has uncontrolled, clinically significant neurological (including seizure disorders), cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urological, immunologic, endocrine disease, or psychiatric disorder, or other abnormality.
• Has a known hypersensitivity to any component of the formulation of TAK-935.
• There is any finding in the participant's medical history, significant results from physical examination, or safety laboratory tests.

Sponsors & Collaborators

• Takeda: lead

Study Sites (1)

Unknown Facility

Lincoln, Nebraska, United States

Location

Results Point of Contact

• Title: Medical Director
• Organization: Takeda

trialdisclosures@takeda.com

+1-877-825-3327

Study Officials

• Medical Director Clinical Science

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2014
• First Posted: July 25, 2014
• Study Start: July 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: July 12, 2016
• Results First Posted: July 12, 2016

Record last verified: 2016-06

Locations

US (1)